Catalog Number

-

Brand Name

Lithotripsy Probe 9FR 54cm

Version/Model Number

9-203-0543

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

Yes

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K130368,K130368

Product Code

FFK

Product Code Name

Lithotriptor, Electro-Hydraulic

Public Device Record Key

1d6929ba-df99-4ea5-8b68-5a72c05688ba

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 13, 2016

Package DI Number

10817183020117

Quantity per Package

3

Contains DI Package

00817183020110

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-